Unmatched Expertise for Biologics, Medical Devices & Combination Products
Our team has a proven track record developing customized programs that leverage our many years of industry-leading experience. We provide the wide range of services and guidances required to launch and maintain successful products in today’s complex regulatory environment.
Leachables StudiesUnderstanding the chemical constituents in your product, delivery system, container or disposable manufacturing components is important to understand and leverage to support safety. Our extractables and leachables program was designed with toxicological safety assessment in mind. And, you can’t do that with a chemistry report full of unknowns. Our team of experts have conducted over 4,500 extractables and leachables studies providing our customers with complete identification. Customized study designs are available to meet your needs. We have experience with ISO, BPOG, ICH and other guidelines.
Contact us at email@example.com to discuss how extractables and leachables studies may be a solution for your next project with your technical experts.